The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...

Process performance qualification (PPQ) Continued process verification (CPV). Pharmaceutical manufacturers have been developing novel methods and solutions to support this new definition of process ...

Process validation is crucial for ensuring the quality ... The second element of PQ involves process performance qualification (PPQ), during which each aspect of the manufacturing process ...

The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. The batches ...

The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. The ...